Comparison of Estrogen and Methyltestosterone Combination Treatments for Postmenopausal Hot Flushes

A Multi-Center, Double-Blind, Placebo-Controlled Comparison of Multiple Doses of Esterified Estrogens and Methyltestosterone, in Combination and Alone, in Relieving Vasomotor Symptoms in Postmenopausal Women

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00160342

Enrollment

1251

Registered

2005-09-12

Start date

2005-06-30

Completion date

2007-09-30

Last updated

2008-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hot Flushes, Menopause, Postmenopause

Keywords

Hormone replacement therapy, hot flushes, postmenopause

Brief summary

This is a research study to evaluate the effectiveness, safety and side effects of several dose levels of esterified estrogens (EE) and methyltestosterone (MT) given individually and in combination compared to a placebo (a tablet with no active drug in it) as a possible treatment for vasomotor symptoms (such as hot flushes and flushing) of menopause. EE and testosterone are two hormones which are typically deficient in menopausal women

Interventions

DRUGEsterified Estrogens (EE) and Methyltestosterone (MT)

oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 65 Years

Healthy volunteers

Inclusion criteria

1. Be able to communicate with the Investigator and study staff and be able to complete the required study procedures, 2. Be a female of any race between the ages of 45-65 years, in generally good health, 3. Be either naturally or surgically postmenopausal (with or without a uterus)

Exclusion criteria

1. Known sensitivity or contraindications to natural or synthetic estrogens, androgens or progestins, 2. History of or current diagnosis of malignant melanoma, breast cancer or any cancer (except non-melanomatous skin cancer) diagnosed less than 5 years prior to beginning the study

Design outcomes

Primary

Measure	Time frame
Mean change in severity of moderate to severe VMS from baseline to Week 12	12 weeks
Mean change in frequency of moderate to severe vasomotor symptoms (VMS) from baseline to Week 4	4 weeks
Mean change in frequency of moderate to severe VMS from baseline to Week 12	12 weeks
Mean change in severity of moderate to severe VMS from baseline to Week 4	4 weeks

Secondary

Measure	Time frame
Frequency and severity of moderate to severe and all hot flushes at each week	12 weeks
Mean change from baseline to Week 12 in the moderate to severe vulvar and vaginal atrophy symptom identified by the subject as most bothersome	12 weeks
Mean change from baseline to Week 12 in vaginal pH	12 weeks
Mean change from baseline to Week 12 in vaginal maturation index (parabasal and superficial cells)	12 weeks

Countries

Canada, Russia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026